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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 March 2022 |
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Main ID: |
NCT02427958 |
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Date of registration:
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23/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
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Scientific title:
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An Open Label, Multicenter Study to Assess the Safety and Efficacy of Leuprorelin in the Treatment of Central Precocious Puberty |
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Date of first enrolment:
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August 7, 2015 |
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Target sample size:
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307 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02427958 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. In the opinion of the investigator, the participant and/or parent(s) or legal guardian
are capable of understanding and complying with protocol requirements.
2. The participant or the participant's parent(s) or legally acceptable representative
signs and dates a written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.
3. Has onset of appearance of secondary sexual characteristic earlier than age 8.0 years
in girls or earlier than 9.0 years in boys and the symptom is persistent, and has
confirmed diagnosis of CPP.
4. Has basal luteinizing hormone (LH) level greater than (>) 5.0 international units per
liter (IU/L) or peak LH >3.3 IU/L with LH/follicle-stimulating factor (FSH) >0.6 in
stimulation test.
5. Has evidence of gonadal development evaluated by ultrasonography: ovarian volume >=1
milliliter (mL) with multiple follicles >=4 millimeter (mm) in any ovary or uterine
enlargement in females or testicular volume >=4 mL in males.
6. Has advanced bone age (BA) >=1 year and BA is less than or equal to (<=) 11.5 years in
females or <=12.5 years in males OR predicted adult height <150 centimeter (cm) in
females or <160 cm in males OR standard deviation score (SDS) <-2 standard deviations
(SD) OR rapid growth defined as growth of BA /growth of chronologic age >1. BA is
determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards at
screening.
7. Has anticipated treatment duration of at least 2 year in investigator's judgment.
8. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 90 days after last dose.
9. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent throughout the duration of the study.
10. The female participant who, at the discretion of the investigator, is deemed to be of
child bearing potential must provide negative urine pregnancy text at Day -1 or Day 1
prior to drug administration.
Exclusion Criteria:
1. Has received any investigational compound within 30 days prior to Screening.
2. Has received gonadotropin-releasing hormone analog (GnRHa) treatment in a previous
clinical study or as a therapeutic agent.
3. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in the conduct of this study (example [eg],
spouse, parent, child, sibling) or may consent under duress.
4. Has any findings in his/her medical history, physical examination, or safety clinical
laboratory tests giving reasonable suspicion of underlying disease that might
interfere with the conduct of the trial.
5. Has any concomitant medical condition that, in the opinion of the investigator, may
expose a participant to an unacceptable level of safety risk or that affects
participant compliance.
6. Has any screening abnormal laboratory value that suggests a clinically significant
underlying disease or condition that may prevent the participant from entering the
study; or the participant has: creatinine >=1.5 milligram per deciliter (mg/dL),
alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the
upper limit of normal (ULN), or total bilirubin >2.0 mg/dL, with AST/ALT elevated
above the limits of normal values.
7. Has a history or clinical manifestations of significant adrenal or thyroid diseases or
intracranial tumor OR has a history of malignant disease.
8. Has a history of hypersensitivity or allergies to leuprorelin, or related compounds
including any excipients of the compound.
9. Has a diagnosis of peripheral precocious puberty.
10. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse within 1 year prior to the Screening Visit.
11. Participant or parent(s), at the discretion of the investigator, is unlikely to comply
with the protocol or is unsuitable for any of other reason.
12. If female, the participant is of childbearing potential (eg, not sterilized).
13. If female, the participant is pregnant or lactating or intending to become pregnant
before, during, or within 1 month after participating in this study; or intending to
donate ova during such time period.
14. If male, the participant intends to donate sperm during the course of this study or
for 90 days thereafter.
15. Has participated in another clinical study and/or has received any investigational
compound within 30 days prior to Screening.
Age minimum:
1 Year
Age maximum:
9 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Central Precocious Puberty
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Intervention(s)
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Drug: Leuprorelin
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Primary Outcome(s)
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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
[Time Frame: Day 1 up to Week 100]
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Secondary Outcome(s)
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Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96
[Time Frame: Week 96]
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Secondary ID(s)
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CTR20140148
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Leuprorelin-4001
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U1111-1183-0353
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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